UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002802 |
|---|---|
| Receipt number | R000003408 |
| Scientific Title | comparison of rosuvastatin alone versus ezetimib plus standard statin on lipid-lowering effects in patients with dyslipidemia |
| Date of disclosure of the study information | 2009/11/26 |
| Last modified on | 2015/12/25 17:22:36 |
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Basic information
Public title
comparison of rosuvastatin alone versus ezetimib plus standard statin on lipid-lowering effects in patients with dyslipidemia
Acronym
comparison of rosuvastatin versus ezetimib/standard statin in patients with dyslipidemia
Scientific Title
comparison of rosuvastatin alone versus ezetimib plus standard statin on lipid-lowering effects in patients with dyslipidemia
Scientific Title:Acronym
comparison of rosuvastatin versus ezetimib/standard statin in patients with dyslipidemia
Region
| Japan |
Condition
Condition
dyslipidemia
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
comparison of rosuvastatin (5mg) alone versus combination of ezetimib (10mg) and standard statin (pravastatin, fluvastatin, or simvastatin) on lipid-lowering effects in dyslipidemic patients with inadequate medication
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
comparison of changes of LDL-C levels between the groups in rosuvastatin monotherapy and ezetimib/standard statin combination therapy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Switch from standard statins (pravastatin, fluvastatin, simbastain) to rosuvastatin (5mg) 1 TAB/day for 12 weeks
Interventions/Control_2
Treat with Ezetimib (10mg) 1 TAB/day for 12 weeks and standard statins (pravastatin, fluvastatin, or simbastain)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Dyslipidemic patients whose serum LDL-C levels are more than 140 mg/dL despite medication of any dose of statins ( pravastatin, fluvastatin, or simbastain).
Written informed consent was given by patients. The study protocol was approved by
the Ethics Committee of Hokkaido University.
Key exclusion criteria
1. Patients who has been treated by any strong statins (rosvastatin, atrovastatin, and pitavastatin) or ezetimib.
2. Patients who are suffered from severe liver, kidney, or heart diseases.
3. Patients who are pregnant, lactating, or could be pregnant
4. Patients with the history of allergy for study drugs.
5. Patients treated with cyclosporin.
6. Patients were deemed inappropriate for this study as the doctor.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Narihito Yoshioka, MD PhD |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Medicine II
Zip code
Address
N-15, W-7, Kita-Ku, Sapporo, Japan
TEL
011-706-5915
n.yoshioka@east.ntt.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | So Nagai, MD PhD |
Organization
Hokkaido University Hospital
Division name
Department of Medicine II
Zip code
Address
N15W7, Kita-ku, Sapporo, Japan
TEL
011-706-5915
Homepage URL
nagai-s@med.hokudai.ac.jp
Sponsor or person
Institute
Department of Medicine II, Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
札幌麻生脳神経外科病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 11 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2009 | Year | 09 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2012 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2012 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 11 | Month | 26 | Day |
Last modified on
| 2015 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003408
